Transcript Activa DBS Therapy Overview. ppt

Instrument of Change
Activa Therapy: Improving Motor Function
for Movement Disorder Patients
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Activa Therapy
• Overview
• Approved Indications for Activa Therapy
– Parkinson’s disease
– Essential Tremor
– Dystonia
• Surgical Procedure
• Patient Management
• Coding and Reimbursement
• Activa in Your Practice
Activa Therapy:
Overview
Activa Therapy
• Also known as deep brain
stimulation, or DBS
• Uses an implanted electrode to
deliver high-frequency electrical
stimulation to structures involved
in the control of movement within
either the:
– Ventral intermediate nucleus of
the thalamus (Vim)
– Subthalamic nucleus (STN)
– Globus pallidus (GPi)
• This electrical stimulation overrides
abnormal neuronal activity within these
brain regions to bring motor controlling
circuits into a more normal state of
function, thereby reducing movement
disorder symptoms
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Approved Indications
• Activa Therapy is approved for the
treatment of symptoms due to:
– Essential Tremor
• FDA approved in 1997
– Parkinson’s disease
• FDA approved in 2002
– Dystonia
• FDA approved (HDE*) in 2003
• Over 30,000 patients implanted worldwide
*Humanitarian Device: Authorized by Federal Law for the use as an aid in the management of
chronic, intractable (drug refractory) primary dystonia, including generalized and segmental
dystonia, hemidystonia, and cervical dystonia, for individuals 7 years of age and older.
Target Sites for Activa Therapy
Vim Thalamus:
Essential Tremor
Subthalamic Nucleus:
Parkinson’s disease
and Dystonia
Globus Pallidus:
Parkinson’s disease
and Dystonia
Activa Therapy: Implantable Components
• Lead
• Extension
• Neurostimulator
(implantable pulse
generator)
Soletra™
Single Channel Output
Kinetra®
Dual Channel Output
External Components
8840 N’Vision®
Clinician Programmer
Access™ Patient
Controller
Access™ Review
Patient Controller
Activa Therapy:
Parkinson’s
Disease
Parkinson’s Disease
• Progressive neurodegenerative disorder
with the cardinal features of:
– Bradykinesia/akinesia
– Tremor
– Rigidity
– Postural instability
• Second most common neurodegenerative
disorder, affecting more than 1 million Americans
Treatments for PD
• Pharmacological treatments
• Supplemental therapies
– Physical therapy
– Speech therapy
– Environmental modification
• Surgical interventions
– Activa Therapy (DBS)
– Ablation
Activa Therapy Improves Some of the
Cardinal Motor Features of PD
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Parkinson’s Disease Treatment:
Continuum of Interventions
Disease Severity
Mild
Signs of levodopa
“wearing-off”
Patient Symptoms
Treatment
Moderate
Agonists
Levodopa, COMT
inhibitors, others
Modified from Giroux, ML and Farris, SF. Cleveland Clinic Foundation 2005
Cleveland Clinic Foundation
Center for Neurological Restoration
Severe
Dyskinesia,
“On-Off”
Motor
Fluctuations
DBS
Postural Instability,
Freezing, Falls, Dementia
Activa Therapy: When
Pharmacotherapy isn’t Enough
• As Parkinson’s disease progresses, medications may fail to
provide consistent and adequate symptom control
• Medications used at levels required for symptom control
may produce adverse effects
– Motor complications, such as dyskinesia
– Cognitive and psychiatric problems
– Nausea, hypotension, and other systemic effects
When Should Activa be Considered?
• When, despite optimized pharmacotherapy,
your patient experiences troubling motor
symptoms, which may include:
– Wearing off – Off periods that contain troubling
bradykinesia, rigidity, tremor, and/or gait difficulty
– Troubling dyskinesia
– Motor fluctuations
– Refractory tremor
Exclusion Criteria for Activa
• Atypical (non-idiopathic) parkinsonism
• Lack of sustained response to levodopa
• Frank dementia, moderate to severe dementia
Most Activa Implanting Centers will review patient
medical history to identify other potential exclusion
criteria & verify patient candidacy for Activa.
Two Questions to Ask Your Patient:
• “How many hours a day do your symptoms
bother you?”
• “Are you satisfied?”
– If they aren’t satisfied with their symptom control
using existing therapy, Activa should be considered
“ON” Time Without Dyskinesias Improves
from 27% to 74% of a Patient’s Waking Day*
19%
27%
7%
49%
74%*
23%
Before Surgery
(n=96)
‘ON’ with Dyskinesia
6 Months After Surgery
Bilateral STN Activa® Implant
(n=91)
‘ON’ without Dyskinesia
* The Deep-Brain Stimulation for Parkinson’s Disease Study Group. Deep-brain stimulation of the subthalamic
nucleus for the pars interna of the globus pallidus in Parkinson’s disease. N Eng J Med. 2001;345:956-63.
‘OFF’
Efficacy: Benefits of Activa Therapy
Impact on Mobility
Dyskinesia
Before
“On” Time
After
“Off” Time
This graph is only for illustrative purposes and
does not represent actual “on” and “off” time.
Efficacy: Benefits of Activa Therapy
for PD Patient Population
87% of patients
demonstrated improved
motor scores in the OFF
medication state at the 12month evaluation .*
* Results were for a subset of patients whose data were verified
against medical records. Data on file at Medtronic, Inc.
Motor Symptoms Improvements
Maintained After 5 Years
• In a 5-year study, ACTIVA significantly improved
OFF-medication assessments of tremor, rigidity,
and akinesia/bradykinesia
OFF-Medication Motor Score Improvements*
6-month
1-year
3 years
5 years
Tremor
79%
75%
83%
75%
Rigidity
58%
73%
74%
71%
Akinesia
42%
63%
52%
49%
*Results for STN
Additional Benefits of Activa
• Bilateral, reversible, and adjustable
• Non-destructive versus ablative procedures
• Can be non-invasively fine-tuned to each
patient’s individual needs
Activa Therapy: Potential
Complications and Risks
• Surgery related
– Hemorrhage (inherent in any stereotactic procedure);
may be silent or symptomatic
– Transient confusion
– Infection (typically occurs at neurostimulator site
in chest when it does occur)
• Stimulation related
– Usually can be minimized or eliminated
by adjusting stimulation settings
– Reversible paresthesia, dysarthria,
muscle contraction
Activa Therapy:
Essential Tremor
Essential Tremor
• The most common movement disorder, affecting
up to 20% of the elderly
• Produces postural tremor disorder (may also
occur at rest); most commonly affects hands
but can also affect head, voice, tongue, and legs
Pharmacologic Treatment of ET
• Beta-blockers
• Antiepileptics
• Benzodiazepines
• Botulinum toxin injections
• Drug-induced adverse
effects common
Questions to Ask Your Patient:
• "How many hours per day do your symptoms bother you?"
• “Are you satisfied with your ability to do the things you
enjoy?”
Video: ET Patient Before & After
Pre-Op
Comparing Pre & Post-Op
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Activa Therapy Efficacy for ET
• 69% of Essential Tremor patients experience total
or significant suppression of disabling tremor *
– This results in significant reduction in disability
• Stimulation-induced adverse effects include transient
paresthesia, dysarthria, and disequilibrium
– Many of the side effects were temporary or improved with
adjustment of electrical parameters
* Data on File. Medtronic, Inc.
Essential Tremor Guidelines
• Guidelines published by the American Academy
of Neurology (AAN) in June 2005 concluded that:
– Unilateral DBS resulted in a significant (60 to 90%)
reduction of contralateral limb tremor
Zesiewicz TA, Elbe R, Louis ED, et al. Practice Parameter: Therapies for
essential tremor. Report of the Quality Standards Subcommittee of the
American Academy of Neurology. Neurology 2005;64:2008-2020
Activa
Therapy:
Dystonia
Pre-Op
Dystonia Video
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Post-Op
Long Term
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Post-Op Short Term
Dystonia
• Syndrome of sustained muscle
contractions, frequently causing
twisting and repetitive movements,
or abnormal postures
• Onset: Mean age = 27, with
bimodal incidence peaks at
9 and 40 years of age
• Dystonic symptoms may be
increased with movement
Pharmacologic Treatment of Dystonia
• Anticholinergics
• Dopaminergic agents
• Benzodiazepines
• Baclofen
• Local injections of botulinum toxin
Activa Therapy for Dystonia
• Currently approved under Humanitarian
Device Exemption (HDE)
*Humanitarian Device Exemption approval for patients 7 years and older
Key DBS Literature
Parkinson's disease
• The Deep-Brain Stimulation for Parkinson’s Disease Study Group. Deep-brain
stimulation of the subthalamic nucleus for the pars interna of the globus
pallidus in Parkinson’s disease. N Eng J Med. 2001;345:956-63.
• Krack P, Batir A, Van Blercam N, et al. Five-year follow-up of bilateral
stimulation of the subthalamic nucleus in advanced Parkinson’s disease.
N Eng J Med. 2003;349:1925-1934.
Essential Tremor
• Koller WC, Lyons KE, Wilkinson SB, et al. Long-term safety
and efficacy of unilateral deep brain stimulation of the thalamus in essential
tremor. Mov Disord. 2001 May;16(3):464-8.
Dystonia
• Coubes P, Roubertie A, Vayssiere N, et al. Treatment of DYT1-generalised
dystonia by stimulation of the internal globus pallidus. Lancet 2000;355:2220
Activa Therapy:
Surgical
Procedure
Surgical Technique
– Stereotactic frame placement
or frameless stereotaxy
– Targeting
• Imaging
• Stereotactic targeting
• Physiologic targeting
(microelectrode recording
and stimulation)
– Electrode placement
– Pulse generator implantation
Surgical Technique: Targeting
• Sophisticated imaging
and software enables
precise targeting for
optimal outcomes and
minimal risk
• Microelectrode recording
(MER) offers additional
levels of verification of
lead location
Surgical Technique:
Microelectrode Recording
Border
10sec
80ms
STN
10sec
80ms
Border/SN
10sec
80ms
Sagittal Section Through the Thalamus
Surgical Technique:
DBS Lead Placement
• Leads placed in motor
territory of nucleus
• Leads have four electrodes
• Multiple electrode
configurations possible
during post-operative
programming
Target Sites for Activa Therapy
Vim Thalamus:
Essential Tremor
Subthalamic Nucleus:
Parkinson’s disease
and Dystonia
Globus Pallidus:
Parkinson’s disease
and Dystonia
Surgical Technique:
Neurostimulator Placement
• Can be done immediately
or days/weeks later
• Typically placed
below clavicle
• Connected to lead using
extension
Activa Patient
Management
Adjustability of Activa Therapy
• Non-invasive adjustment of
parameters to maximize benefit
and minimize adverse effects
• Selection of electrodes allows
adjustment of the site of stimulation
• Adjustment of parameters allows
control over amount of therapy
• Adjustments generally are
few once optimal parameters
are achieved
Coding &
Reimbursement
Commonly Billed Codes
Neurologist
Physician Coding & Reimbursement for Programming
Code
Description
2005 Medicare
National Avg. in
Office Setting
2005 Medicare
National Avg. in
Outpatient Setting
95970
Electronic analysis of IPG, without
reprogramming
$50.40
$23.50
95978*
Electronic analysis of deep brain IPG
with programming, 1st hour
$212.60
$188.73
95979*
Electronic analysis of deep brain IPG
with programming, each add’l 30
minutes after 1st hour
$98.15
$91.33
*CPT 95972 & 95973 are reassigned to CPT 95978 & 95979 for 2005, specifically for the
analysis & reprogramming of a deep brain neurostimulator pulse generator.
2005 Medicare National Payment based on 2005 Medicare RVUs and conversion factor
($37.8975)
as published in the November 3, 2004 Federal Register. Individual physician
reimbursement will vary.
High Volume Neurology Codes
Code
Description
2005 Medicare
Fee Schedule
Average Time
(minutes)
Revenue per
Hour
Procedures
95903
Motor NCT
$69.73
30-60
$70-139
95816
EEG
$187.59
30-60
$188-375
95860
Needle EMG
$92.85
15-30
$186-371
95974
VNS
Programming
and Analysis
$184.56
10-20
$554-1107
95978
DBS
Programming
and Analysis
$212.61
15-60
$213-850
This table compares revenue and time utilization for high volume neurology patient care
and codes. The time and revenue will vary based on variances in clinical practice.
Activa in Your Practice
• Establish how you want to work with the Activa
center in your area
• Partner with Medtronic to develop a training
program for you and your staff
• Identify, educate, and refer appropriate patients
Working with the Activa Center
• Become familiar with the center where you will refer
patients for Activa Therapy
– Your Medtronic Therapy Consultant will assist you in meeting
members of the local Activa center
• Determine your desired role in working with Activa patients
– Participate in post-implant management of Activa Therapy
(programming the device)
– Refer for implant, with Activa center managing stimulation
programming; continue to manage non-Activa issues
• View an Activa Therapy system surgical implant or
programming clinic
Training for You and Your Staff
• Partner with Medtronic for a full range
of educational opportunities designed to
further your therapeutic success
• Medtronic Activa Therapy’s Curriculum
For Life provides the framework to
support your professional growth as
you develop and expand your expertise
• www.activauniversity.com
Building a Curriculum and
Designing a Pathway for Success
Toward Lifelong Learning
Identify, Educate, and
Refer Appropriate Patients
• Medtronic can support you with patient education
materials
• Activa Ambassador
– Gives patients the opportunity to consult and interact with an
implanted patient
• Introduction to Activa Event
– Physician-directed patient events designed to identify Activa
candidates
Activa Therapy is Rewarding
Sooner Can be Better than Later
“…stimulation therapy should be considered . . . before the
development of a major disability that threatens their
employment and their roles in their family and in society.”
AE Lang. Subthalamic Stimulation for Parkinson’s Disease – Living Better Electrically?
N Engl J Med 2003;1888-91.
Disclosure Statement/Contraindications
Indications:
Parkinson’s Control Therapy: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN)
using Medtronic® Activa® Parkinson’s Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of
advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.
Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic® Activa® Tremor Control System is indicated for
the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential
Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant
functional disability. The safety or effectiveness of this therapy has not been established for bilateral stimulation.
Dystonia Therapy: Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) by
the Medtronic Activa System is indicated as an aid in the management of chronic, intractable (drug refractory) primary
dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7
years of age and older.
Contraindications: Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil
or a head transmit coil that extends over the chest area, patients who are unable to properly operate the neurostimulator, or
for Parkinson’s disease and Essential Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g.,
shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's
energy can be transferred through the implanted system (or any of the separate implanted components), which can cause
tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.
Disclosure Statement/Contraindications
Warnings/ Precautions/Adverse Events: There is a potential risk of tissue damage using stimulation parameter settings of
high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with a heightened risk of
intracranial hemorrhage. Do not place the lead-extension connector in the soft tissues of the neck. Placement in this location
has been associated with an increased incidence of lead fracture. Theft detectors and security screening devices may cause
stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in perceived stimulation.
Although some MRI procedures can be performed safely with an implanted Activa System, clinicians should carefully weigh the
decision to use MRI in patients with an implanted Activa System. MRI can cause induced voltages in the neurostimulator and/or
lead possibly causing uncomfortable, jolting, or shocking levels of stimulation. MRI image quality may be reduced for patients
who require the neurostimulator to control tremor, because the tremor may return when the neurostimulator is turned off.
Severe burns could result if the neurostimulator case is ruptured or pierced. The Activa System may be affected by or adversely
affect medical equipment such as cardiac pacemakers or therapies, cardioverter/defibrillators, external defibrillators, ultrasonic
equipment, electrocautery, or radiation therapy. Safety and effectiveness has not been established for patients with neurological
disease other than Parkinson’s disease or Essential Tremor, previous surgical ablation procedures, dementia, coagulopathies,
or moderate to severe depression; or for patients who are pregnant, under 18 years, over 75 years of age (Parkinson’s Control
Therapy) or over 80 years of age (Tremor Control Therapy). For patients with Dystonia, age of implant is suggested to be that at
which brain growth is approximately 90% complete or above. Additionally, the abrupt cessation of stimulation for any reason
should be avoided as it may cause a return of disease symptoms. In some cases, symptoms may return with an intensity
greater than was experienced prior to system implant (“rebound” effect). Adverse events related to the therapy, device, or
procedure can include: stimulation not effective, cognitive disorders, pain, dyskinesia, dystonia, speech disorders including
dysarthria, infection, paresthesia, intracranial hemorrhage, electromagnetic interference, cardiovascular events, visual
disturbances, sensory disturbances, device migration, paresis/asthenia, abnormal gait, incoordination, headaches, lead
repositioning, thinking abnormal, device explant, hemiplegia, lead fracture, seizures, respiratory events, and shocking or jolting
stimulation.
Humanitarian Device: Authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug
refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for
individuals 7 years of age and older.